Published Articles

The Issues & Challenges Involved in In Vitro Release Testing for Semi-Solid Formulations

The use of an in vitro release test (IVRT) to evaluate drug release from semi-solid formulations has become the routine test for topical product development. Like the dissolution test for solid dosage forms, IVRT for semi-solid dosage has become increasingly important. As FDA Guidance puts it, “In vitro release is one of several standard methods that can be used to characterize performance characteristics of a finished topical dosage form (ie, semi-solids like creams, gels, and ointments)… A variety of physical and chemical tests commonly performed on semi-solid products and their components (eg, solubility, particle size, and crystalline form of the active component, viscosity, and homogeneity of the product) have historically provided reasonable evidence of consistent performance. More recently, IVRT has shown promise as a means to comprehensively ensure consistent delivery of the active component(s) from semi-solid products.

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